Anti-CD20 Antibody Therapy for Sjogren's Syndrome

NCT00101829 | Completed Phase 1 DMC

• 1 other identifier: DAIT ASJ01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Sjogren's syndrome (SS). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with SS, a disease of the immune system. However, the safety of rituximab in SS patients must first be established.

Conditions

Sjogren's Syndrome

Keywords

Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

• Count of Participants with Rituximab Related Grade 3 or higher AEs

  The study site will grade the severity of adverse events (AEs) experienced by the study participants according to the criteria set forth in the National Cancer Institute's Common Toxicity Criteria for Adverse Events Version 3.0 (published June 10, 2003).

  Throughout study

Study Arms (1)

Rituximab Treatment

EXPERIMENTAL

Participants will receive rituximab at study entry and at Week 2

Drug: Rituximab

Interventions

Rituximab DRUG

1000 mg intravenous infusion

Also known as: Rituxan

Rituximab Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weighs at least 40 kg (88.2 lbs)
• Meets European criteria proposed by the American-European Consensus Group for primary Sjogren's syndrome
• Has 1 or more of the following symptoms of Sjogren's syndrome: fatigue; joint pain; peripheral neuropathy; interstitial lung disease; leukocytoclastic vasculitis; renal tubular acidosis; interstitial nephritis; severe parotid swelling; or other extraglandular manifestations causing organ system dysfunction
• Agrees to use acceptable methods of contraception during the study and for 12 months after the end of treatment

You may not qualify if:

• Active infection
• Chronic or persistent infection which might be worsened by immunosuppressive treatment (e.g., HIV, hepatitis B or C, tuberculosis \[TB\])
• Known coronary artery disease, significant cardiac arrhythmias, or severe congestive heart failure (New York Heart Association class III or IV)
• Current use of anticoagulants
• Prior use of rituximab
• Cyclophosphamide treatment within 24 weeks prior to screening
• Certain medications that may cause dry mouth
• Cytotoxic therapy with azathioprine, cyclosporine, methotrexate, or mycophenolate mofetil within 4 weeks prior to screening
• Etanercept within 4 weeks prior to screening
• Adalumimab within 8 weeks prior to screening
• Infliximab within 12 weeks prior to screening
• Prednisone at greater than 10 mg/day within 2 weeks prior to screening. Patients who have their steroid doses tapered to 10 mg/day or less within 2 weeks of screening are not excluded.
• Definitive diagnosis of another autoimmune rheumatologic disease (e.g., systemic lupus erythematosus, scleroderma, rheumatoid arthritis)
• History of alcohol or substance abuse
• History of immunoglobulin E (IgE)-mediated or non-IgE-mediated hypersensitivity

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Autoimmunity Centers of Excellence: collaborator

Study Sites (2)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6160, United States

Location

Related Publications (4)

• Boye J, Elter T, Engert A. An overview of the current clinical use of the anti-CD20 monoclonal antibody rituximab. Ann Oncol. 2003 Apr;14(4):520-35. doi: 10.1093/annonc/mdg175.

  PMID: 12649096 BACKGROUND

• Cheson BD. Rituximab: clinical development and future directions. Expert Opin Biol Ther. 2002 Jan;2(1):97-110. doi: 10.1517/14712598.2.1.97.

  PMID: 11772344 BACKGROUND

• Looney RJ, Anolik J, Sanz I. B cells as therapeutic targets for rheumatic diseases. Curr Opin Rheumatol. 2004 May;16(3):180-5. doi: 10.1097/00002281-200405000-00003.

  PMID: 15103242 BACKGROUND

• St Clair EW, Levesque MC, Prak ET, Vivino FB, Alappatt CJ, Spychala ME, Wedgwood J, McNamara J, Moser Sivils KL, Fisher L, Cohen P; Autoimmunity Centers of Excellence. Rituximab therapy for primary Sjogren's syndrome: an open-label clinical trial and mechanistic analysis. Arthritis Rheum. 2013 Apr;65(4):1097-106. doi: 10.1002/art.37850.

  PMID: 23334994 RESULT

Related Links

• National Institute of Allergy and Infectious Diseases (NIAID)

MeSH Terms

Conditions

Sjogren's Syndrome; Autoimmune Diseases

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Philip L. Cohen, MD

  Rheumatology Division, University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• E. William St. Clair, MD

  Division of Rheumatology and Immunology, Duke University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2005
• First Posted: January 14, 2005
• Study Start: April 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2009
• Last Updated: October 20, 2017

Record last verified: 2017-10

Locations

US (2)